Differential Response to the Three Therapies Based on Fixed Threshold Criteria for the Following Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations and Asthma Control Days. [ Time Frame: The last 14 weeks of each 16-week treatment period ]

The primary outcome was differential response to the three therapies on the basis of fixed threshold criteria for the following asthma control measures, which encompassed domains of risk and impairment: the time from the start of the treatment period to an asthma exacerbation treated with systemic corticosteroids, and the annualized number of asthma control days (ACDs) from within that period. ACDs were defined as full calendar days without symptoms, rescue medication use, or unscheduled healthcare visits. Children were defined as differential responders if, first, the time to an asthma exacerbation was at least four weeks longer, or second, if the number of annualized ACDs was at least 31 days more for one treatment than another, in that order. If neither threshold was met, the participant was considered a non differential responder. Differential response was determined in children completing at least two treatment periods and at least 50% of the daily diary entries for each period.

INFANT is a double-blind, randomized clinical trial in which all participants will receive each of the three therapies for 16 weeks by means of a cross-over study design. INFANT aims to determine whether individual children respond better to one treatment than another and, if so, whether those children can be identified by phenotypic characteristics or selected biomarkers. In this regard the INFANT study is expected to address critical gaps in current asthma management guidelines. Ultimately, the findings from this study are expected to help clarify treatment modalities for this population of young preschool children who are extremely difficult to treat.

Eligibility

Ages Eligible for Study:

12 Months to 59 Months (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

12-59 months of age.

If the child is not currently taking long-term asthma controller therapy (meaning that the child has taken no inhaled corticosteroid or leukotriene receptor antagonist medication whatsoever over the past 6 months), then one of the following criteria must be met:

Daytime asthma symptoms more than two days per week (average over the past 4 weeks),

At least one nighttime awakening from asthma (over the past 4 weeks),

Two or more asthma exacerbations requiring systemic corticosteroids in the previous 6 months,

Four or more wheezing episodes in the previous 12 months.

If the child is currently taking long-term asthma controller therapy (meaning that the child has taken daily or intermittent/as-needed inhaled corticosteroid or leukotriene receptor antagonist over the past 6 months), then one of the following criteria must be met:

Taking inhaled corticosteroid or leukotriene receptor antagonist for more than 3 months (or more than 90 days) out of the previous 6 months (or 180 days),

Daytime asthma symptoms more than two days per week (average over the past 4 weeks),

More than one nighttime awakening from asthma (over the past 4 weeks),

Two or more asthma exacerbations requiring systemic corticosteroids in the previous 12 months,

Four or more wheezing episodes in the previous 12 months.

Up to date with immunizations, including varicella (unless the subject has already had clinical varicella).

Willingness to provide informed consent by the child's parent or guardian.

Exclusion Criteria:

Allergic reaction to the study medications or any component of the study drugs, including (but not limited to) urticaria, rash, angioedema, or hypotension following delivery,

Significant developmental delay/failure to thrive, defined as 5th percentile for height and/or weight or crossing of two major percentile lines during the last year for age and sex,

History of a near-fatal asthma exacerbation requiring intubation or assisted ventilation,

No primary medical caregiver (e.g., a nurse practitioner, physician assistant, physician, or group medical practice such as a hospital-based clinic) whom the subject can contact for primary medical care,

Three or more hospitalizations in the previous 12 months for wheezing or respiratory illnesses,

Treatment with 5 or more courses of systemic corticosteroids (oral, intramuscular or intravenous) in the past 6 months,

Current use of higher than step 2 NAEPP asthma guideline therapy

If receiving allergy shots, change in the dose within the past 3 months.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606306

Locations

United States, Arizona

University of Arizona College of Medicine

Tucson, Arizona, United States, 85724

United States, California

Children's Hospital & Research Center Oakland

Oakland, California, United States, 94609

UCSF Benioff Children's Hospital

San Francisco, California, United States, 94143

United States, Colorado

National Jewish Health

Denver, Colorado, United States, 80206

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

United States, Illinois

Rush University Medical Center/Stroger Hospital

Chicago, Illinois, United States, 60612

Children's Memorial Hospital

Chicago, Illinois, United States, 60614

United States, Massachusetts

Children's Hospital, Boston

Boston, Massachusetts, United States, 02115

United States, Missouri

St. Louis Children's Hospital

St. Louis, Missouri, United States, 63110

United States, Ohio

Rainbow Babies and Children's Hospital, Case Western Reserve University